NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1-1/4" CTF 14602

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-19 for NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1-1/4" CTF 14602 manufactured by Hollister Incorporated.

Event Text Entries

[136502131] Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers. Dhr review not possible because lot number not known. Sample review not possible because no sample available. Trend data reviewed and no adverse trend observed. Weight of end user not known so estimation was used.
Patient Sequence No: 1, Text Type: N, H10


[136502132] It was reported that an end user experienced blisters and a rash which started under the tape portion of the ostomy barrier but extended to her pubic area. The blisters were pus-filled. End user was prescribed amoxicillin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119193-2019-00007
MDR Report Key8350486
Report SourceCONSUMER
Date Received2019-02-19
Date of Report2019-02-19
Date of Event2019-02-13
Date Mfgr Received2019-02-14
Date Added to Maude2019-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDA WISOWATY
Manufacturer Street2000 HOLLISTER DRIVE
Manufacturer CityLIBERTYVILLE. 600483781
Manufacturer CountryUS
Manufacturer Postal600483781
Manufacturer Phone8476802170
Manufacturer G1HOLLISTER INCORPORATED
Manufacturer Street366 DRAFT AVENUE
Manufacturer CitySTUARTS DRAFT VA 244779998
Manufacturer CountryUS
Manufacturer Postal Code244779998
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1-1/4" CTF
Generic NameNEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER
Product CodeEXB
Date Received2019-02-19
Catalog Number14602
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLLISTER INCORPORATED
Manufacturer Address2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US 600483781


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-02-19

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